Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder
ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
The overall goal of this study is to investigate the added benefit of a neuromodulation intervention in individuals taking medication for treatment for Opioid Use Disorder(OUD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to provide consent and comply with study procedures
Diagnostic and Statistical Manual of Mental Disorders criteria for OUD
Undergoing medication treatment for OUD. Participants may have current comorbid drug use, but primary diagnosis must be OUD
Intention to remain in the study until intervention completion.
Disqualifiers
Any medical condition with neurological sequelae
Head injury resulting in skull fracture or loss of consciousness of >30 minutes
Any tDCS or MRI contraindication (tDCS: history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp. MRI: unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, or claustrophobia)
Any psychotic disorder (participants with other treated and stable psychiatric disorders will be included)
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Direct Current Stimulation (tDCS)
DeviceWe will deliver 2-mA tDCS current intensity during a 30 minute stimulation period (including a 30-second ramp-up and 30-second ramp-down period) to the dorsolateral prefrontal cortex. Electrodes will be fixed on marked locations based on the 10-20 EEG system. Anodal stimulating electrode will be over the left DLPFC (F3) and cathodal electrode over the right DLPFC (F4).
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: tDCSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
tDCS effect on circuit-based target engagement of a prefrontal-incentive salience network
Compare change in correlation value (which represents the functional connectivity between pre-frontal cortex and prefrontal-incentive salience network) via paired t-test, from pre- to post-intervention
Time frame
immediately after the intervention2
tDCS effect on executive functioning
Measure change in cognitive performance via repeated measured t-test from pre- intervention cognitive assessment to post- intervention cognitive assessment (post-intervention mean cognitive score minus pre-intervention mean cognitive score)
Time frame
immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov